Search Results

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device's kit includes a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

The provided text describes the Minuteful-kidney test (K222921) and its substantial equivalence to a predicate device (K210069). However, it specifically states that "The rest of the analytical performance studies are still relevant for the modified version of the Minuteful - kidney test, and their summary is available in the predicate device documentation (K210069)." This means the detailed acceptance criteria and the comprehensive study demonstrating the device meets those criteria are not present in this document but are referenced as being in the predicate device's documentation.

Therefore, I can report on the studies performed for K222921 to assert its substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance from this document for the overall device functionality as those details are in K210069. Nor can I provide information regarding sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for K222921's overall performance since those are tied to the K210069 submission.

The studies described in K222921 (the current device) are focused on demonstrating that changes made to the device in K222921 do not negatively impact performance, thus maintaining substantial equivalence to its predicate.

Here's an analysis based solely on the provided text for K222921, noting the limitations:

Acceptance Criteria and Device Performance (Limited to K222921 changes):

Since the comprehensive performance data is referenced in K210069, the "acceptance criteria" discussed here are implicitly related to demonstrating that the modifications in K222921 (e.g., multilingual support, software enhancements) do not degrade the performance previously established for K210069. The studies conducted for K222921 focused on the robustness of the Image Validation Transfer System (IVTS) and the analytical limits of detection.

Study Details (for K222921 specific enhancements):

1. Sample size used for the test set and the data provenance:

   • Limit of Detection (LoD): The document does not specify the sample size for the LoD study for K222921. It mentions the study was designed and executed according to CLSI document EP17-A2.
   • Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board Studies: The document refers to "Tested smartphones" and "different conditions," but specific numerical sample sizes (e.g., number of images, tests, or smartphones) are not provided. The data provenance is implied to be laboratory-controlled since these are experimental conditions, but no explicit country of origin or retrospective/prospective nature is stated for these new studies. The overall device is intended for home use, so these validations mimic adverse home conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the K222921 document. These types of analytical studies typically rely on reference methods or scientifically established standards rather than expert consensus. For the clinical performance, the document refers to the predicate device K210069, where such details would likely be found if applicable.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided for these specific analytical studies. The assessment of whether performance was "not impacted" would likely come from statistical analysis against pre-defined thresholds.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC or comparative effectiveness study involving human readers with and without AI assistance is mentioned in the K222921 submission. This device is an in-vitro diagnostic home-use test system where the smartphone app performs the measurement, rather than assisting a human in interpreting diagnostic images. Thus, the concept of "human readers improve with AI" in a traditional MRMC sense does not directly apply to this device's function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The core of the described studies (LoD, Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board) are indeed standalone performance tests of the device's algorithmic capability to accurately read the test strip under various challenging conditions encountered in a home setting. The device is described as having "image recognition algorithms" and performing "image analysis activities."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the analytical studies described (LoD, Illumination, etc.), the ground truth would be based on controlled experimental conditions and potentially quantitative reference measurements (e.g., known concentrations for LoD, controlled lighting conditions). The document does not specify the exact methods for establishing this ground truth but implies scientific rigor (e.g., "in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2"). For the clinical performance aspects, the document refers to K210069.

7. The sample size for the training set:

   • Not provided in the K222921 document. Training set details would typically be part of the initial K210069 submission for the machine learning algorithms.

8. How the ground truth for the training set was established:

   • Not provided in the K222921 document. This information would be found in the K210069 submission, likely involving laboratory-controlled tests with known analyte concentrations and reference methods for accurate measurement.

Ask a specific question about this device

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

Here's a breakdown of the acceptance criteria and study information for the Healthy.io Minuteful - kidney test (K210069), based on the provided document:

Acceptance Criteria and Device Performance for Minuteful - kidney test (K210069)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by reporting performance results against the predicate device that demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: More than 450 subjects were recruited for the clinical trials.
• Data Provenance: The document does not explicitly state the country of origin. The study was a prospective clinical trial, as subjects were "recruited" and tasks were "completed" within the context of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth was established by comparing the Minuteful - kidney test results to those obtained from a professional user performing the test on the URISCAN Optima Urine Analyzer (predicate device).

• Number of Experts: Not explicitly stated as a count of individual professionals, but referred to as "a professional user." It's implied that this
  professional operated the predicate device.
• Qualifications: "Professional user" suggests trained laboratory or healthcare personnel familiar with operating the URISCAN Optima Urine Analyzer and interpreting its results. Specific credentials (e.g., medical technologist, clinical laboratory scientist, years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved a 2-part comparison:

1. A lay user (subject in the clinical trial) performed the test using the Minuteful - kidney test app.
2. A professional user (operating the predicate device, URISCAN Optima Urine Analyzer) then performed the test on the same urine sample.

The professional user was blinded to the results of the lay user until after they had completed their test. This can be considered a form of adjudication where the predicate device's result, as read by a professional, serves as the comparison benchmark. There was no explicit multi-expert consensus or 2+1/3+1 method described for establishing a single "ground truth" independent of the comparison devices; rather, the predicate device's output was the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing multiple human readers with and without AI assistance on the same cases. The study compared a lay user with the AI-powered device to a professional user with a predicate device. It was a method comparison study to show substantial equivalence, not a study evaluating human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The clinical performance study involved a lay user interacting with the smartphone application and performing the test steps guided by the app. While the app uses "image recognition algorithms" and "machine learning algorithmic components," it is not a purely standalone algorithm-only performance assessment in the sense of a laboratory-based algorithm evaluation without human interaction for image capture and strip preparation. However, the analytical performance testing (Precision, Interference, Limit of Detection, Linearity, Stability) would represent the closest to "standalone" algorithm performance testing, as these evaluate the device's technical capabilities in a controlled environment. The linearity study, showing 100% exact match for every level of albumin, creatinine, and ACR, is a strong indicator of the core algorithm's accuracy at different concentrations.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device (URISCAN Optima Urine Analyzer) operated by a professional user. This is a form of reference standard comparison where the predicate device's output serves as the truth.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the device's algorithms.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth was established for the training set of the device's algorithms. It only describes the ground truth for the clinical performance (test set) comparison.

Ask a specific question about this device

The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations.

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) can be read by the Mission® U120 Urine Analyzer.

The provided document describes the clinical performance and acceptance criteria for the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) device. This device is intended for the semi-quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer, to assist in diagnosing kidney function.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the new device against a predicate device (CLINITEK Microalbumin Reagent Strips) to establish substantial equivalence. The primary performance metric presented is agreement in classifying Albumin-to-Creatinine (A:C) ratios.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 390 urine specimens.
• Data Provenance: Retrospective, collected randomly at three clinical sites from patients. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Diego, CA, suggesting U.S. clinical sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The "ground truth" for the test set was established by comparing the results of the new device (Mission® Urinalysis Reagent Strips read by Mission U120 Urine Analyzer) to the predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). No independent human experts were stated to have established a separate ground truth for the clinical accuracy study. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set:

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The study directly compares the results of the new device against the predicate device for each specimen.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic (IVD) test strip read by an analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, the performance study is a standalone evaluation of the device system (reagent strips + analyzer). The device itself performs the semi-quantitative measurement. While human operators are involved in dipping the strips and initiating the reading, the "performance" described is that of the automated analytical system in interpreting the strip's reaction.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy study was the results obtained from a legally marketed predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a traditional IVD device like this, the development and calibration of the reagent strips and analyzer would involve extensive internal testing and optimization, but it's not typically referred to as a "training set" in the same way as for AI algorithms. The clinical accuracy study used 390 specimens.

9. How the Ground Truth for the Training Set Was Established:

As there's no explicitly defined "training set" in the AI sense for this type of IVD device, the method for establishing its ground truth isn't applicable. The performance is based on the chemical reactions of the strips and the optical reading capabilities of the analyzer, which would have been rigorously developed and validated against known concentrations of analytes and reference methods during the product development phase.

Ask a specific question about this device

Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.

Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure.

Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.

Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.

Teco Microalbumin 2-1 Combo Strips are designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. The strips are read by visual comparing color chart.

I apologize, but the provided text from the FDA 510(k) letter for the "Teco Microalbumin 2-1 Combo Strips" does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This document is primarily a notification of substantial equivalence for a medical device, indicating that the device has been cleared for marketing based on its similarity to existing legally marketed devices. It outlines the regulatory classification, product codes, and general controls applicable to the device.

To fully answer your request, I would need access to the actual 510(k) submission document or a separate study report, which is not included in the provided text. The provided text only confirms the device's clearance and its intended use.

Ask a specific question about this device

For IN VITRO diagnostic use.

There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L.

Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).

Not Found

The provided document is a 510(k) clearance letter from the FDA for the ImmunoDip™ Urinary Albumin Test. It indicates that the device is substantially equivalent to a legally marketed predicate device.

However, the document DOES NOT contain information regarding:

• Specific acceptance criteria values or a table of reported device performance values. The document only states the device "classifies samples as positive based on their being above or below a level of 18 mg/L."
• A detailed description of any study proving the device meets acceptance criteria. It refers to "Scientific studies indicate that proper control of blood glucose...help slow or prevent kidney damage," but this is background information, not a study of the ImmunoDip device itself. Similarly, "One study found 45% of the insulin-dependent diabetics develop serious kidney disease" is general epidemiological data.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Based on the available information from the document, here's what can be extracted, along with the acknowledgement of missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not specified in the provided text.

4. Adjudication Method for the Test Set:

• Not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, the document does not mention an MRMC study or comparative effectiveness with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The device is described as an "ImmunoDip™ Urinary Albumin Test," implying a rapid diagnostic test kit rather than a software algorithm. Therefore, "standalone algorithm performance" as typically understood for AI/software devices is not applicable or discussed.

7. The Type of Ground Truth Used:

• Not specified in the provided text. The device is intended to classify samples based on an 18 mg/L threshold, implying a quantitative measurement of urinary albumin would be the "ground truth" against which the test's classification is compared, but this is not explicitly stated as the methodology for evaluation.

8. The Sample Size for the Training Set:

• Not specified in the provided text.

9. How the Ground Truth for the Training Set was Established:

• Not specified in the provided text.

Summary of what is present:

• Device Name: ImmunoDip™ Urinary Albumin Test
• Indications for Use: For IN VITRO diagnostic use. To determine albumin in urine at low levels (microalbuminuria), classifying samples as positive if above 18 mg/L. Helpful for early detection and treatment of patients at risk for renal disease (e.g., Type 1 and Type 2 diabetes, hypertension, renal disease in pregnancy).
• Regulatory Clearance: 510(k) clearance (K022538) from FDA, determined substantially equivalent to a predicate device. Regulatory Class I, Product Code JIR.

Limitations:

The provided document is limited to the FDA's 510(k) clearance letter and an "Indications for Use" statement. It does not contain the detailed study protocols, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication. For that information, one would need to refer to the full 510(k) submission K022538, which is often available through the FDA's public database.

Ask a specific question about this device

Ask a specific question about this device

The ImmunoDip™ Urinary Albumin Screen tests for the presence of elevated levels of albumin in urine. Elevated urinary albumin is also known as microalbuminuria. Elevated albumin is an early sign of possible kidney damage. Detection of elevated urinary albumin can aid in the early detection and monitoring of the course of incipient nephropathy in diabetics and hypertensive patients. For IN VITRO diagnostic use.

ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip which is encased in a plastic housing. The ImmunoDip™ Urinary Albumin Screen is placed into a urine sample for at least three minutes and is then removed and read. Results are determined by visually comparing the relative color intensity of two blue bands to obtain a semi-quantitative result of Negative (<= 18 mg/L) or Positive (>18 mg/L).

ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip containing monoclonal mouse antibodies against human serum albumin bound to colored latex beads. Human albumin is fixed in a band at the bottom half of the testing region. Goat anti-mouse antibodies are fixed in a band at the top half of the testing region. The dipstick is encased in an open-ended plastic housing.

When the dipstick is placed into a urine sample cup, the urine sample migrates up the test strip. Albumin present in the urine binds with blue colored latex beads present in the strip. Both beads and albumin are carried up the device by capillary action. At low levels of albumin, the great majority of blue beads are bound at the lower band containing human albumin. At higher levels of albumin, many of the beads pass through the lower band and are bound at the upper band. Levels of albumin above the decision level value of 18 mg/L will produce color on the upper band which is darker than the lower band. By observing the appearance of the two lines, the user can semi-quantitatively determine the urine microalbumin concentration as either Negative (<=18 mg/L), or Positive (>18 mg/L).

The ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip intended to detect elevated levels of albumin in urine (microalbuminuria), which can indicate early kidney damage in high-risk patients.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study: The sample size for the "test set" in the precision study is not explicitly stated in terms of number of urine samples. It refers to "two levels of albumin in urine" and "all instances of within-day, between-day, within-run and between-run testing" with 100% agreement.
• POL Studies: "Six proficiency samples over a clinically relevant range of concentrations (4.5 mg/L, 9.0 mg/L, 15 mg/L, 22 mg/L, 36 mg/L and 72 mg/L)." The number of users (professional and POL users) and the number of replicates (15 replicates within-run, 5 different days between-runs, 3 POL sites between sites) contribute to the overall sample size but the exact number of unique "test set" samples is not provided.
• Clinical Studies: For comparison against predicate methods, "clinical urine samples" were used, but the specific number of these samples is not mentioned.
• Data Provenance: The document does not explicitly state the country of origin for the data. The submitter is based in Canada. The POL studies involved "Physician Office Laboratory (POL) studies" and "3 POL sites," implying real-world settings, but whether these were prospective or retrospective is not specified for all studies. The precision study was an "internal 20 day precision study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Precision Study: "two operators and two additional observers" were involved in determining agreement. Their qualifications are not specified beyond "operators" and "observers."
• POL Studies: "expected results" were used as the ground truth for the 6 proficiency samples. The method or expertise used to establish these "expected results" is not detailed.
• Clinical Studies: The "ground truth" was established by two predicate quantitative methods: the Beckman Array (K922273) and the Kamiya (Crestat) Microalbumin Assay (K934146), and one semi-quantitative method, the DCLare™ ImmunoDip™ Stick for Microalbuminuria (K972337).

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1).
• In the precision study, 100% agreement was obtained between "two operators and two additional observers," implying direct consensus or agreement without needing a tie-breaker.
• For the POL and clinical studies, the results were compared against an "expected result" or predicate device results, not against a human adjudicated consensus derived from multiple readers of the ImmunoDip device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study, as typically understood in the context of comparing human readers with and without AI assistance, was not conducted.
• The studies involved comparing the ImmunoDip device's performance by "POL users" versus "trained laboratory personnel" and against established "predicate methods." There is no mention of an "AI assistance" component or an effect size for human readers improving with AI.

6. Standalone (Algorithm Only) Performance

• The ImmunoDip™ Urinary Albumin Screen is a visual immunochromatographic test strip read by a human. Therefore, a standalone "algorithm only" performance study in the sense of a fully automated AI system without human interaction was not conducted, as the device itself is not a software algorithm. Its performance is the "standalone" performance based on visual interpretation.

7. Type of Ground Truth Used

• Precision Study: The ground truth was based on the consensus ("100% agreement") among two operators and two observers for known albumin levels (two levels specified).
• POL Studies: The ground truth for the proficiency samples was "expected results," which implies they were pre-determined values for the proficiency samples. The method of determination for these "expected results" is not specified but would typically come from a reference method or certified values.
• Clinical Studies: The ground truth was established by two full quantitative predicate methods (Beckman Array, Kamiya Microalbumin Assay) and one semi-quantitative predicate method (DCLare™ ImmunoDip™ Stick for Microalbuminuria).

8. Sample Size for the Training Set

• The document implies that the device is a test strip read visually by a human, not a machine learning or AI algorithm that requires a "training set" in the typical sense. Therefore, the concept of a "training set" as it relates to AI development is not applicable here. The studies described are for validation of the chemical-biological test strip and human interpretation.

9. How the Ground Truth for the Training Set Was Established

• As the device is not an AI algorithm requiring a training set, this question is not applicable.

Ask a specific question about this device

Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips that contain reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein to creatinine ratio is also determined. The strips are read visually by comparison to a color chart on the bottle label. The "NEW MULTIPLES" Reagent Strips can also be read instrumentally on the CLINITEK®50, CLINITEK® 100, CLINITEK® 200+ and CLINITEK® 500 Urine Chemistry Analyzers.

Bayer's "NEW MULTIPLES" Reagent Strips are intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism (e.g., diabetes mellitus), urinary tract infections and liver function. The strips also measure physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. Bayer's "NEW MULTIPLES" Reagent Strips are for professional use in Point -Of-Care locations such as physicians offices or clinics and centralized laboratory locations such as in hospitals.

Bayer's "NEW MULTIPLES" Reagent Strips are firm plastic strips for urinalysis that contain reagent areas for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, blood, glucose, ketone (acetoaceticacid), nitrite, pH, specific gravity, bilirubin, and urobilinogen. A protein-to-creatinine ratio is also determined. New Multiples Reagent Strips are manually dipped into a urine specimen and "read" visually using a color chart. "NEW MULTIPLES" Reagent Strips may also be read instrumentally, using the CIINITEK® family of Urine Chemistry Analyzers. The method is designed for use with random, overnight or timed specimens. Semi-quantitative results are available within one minute.

The provided document describes a 510(k) submission for "NEW MULTIPLES" Reagent Strips for urinalysis. However, it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance thresholds with numerical data, such as sensitivity, specificity, or agreement percentages against a gold standard. Instead, it offers a general statement about performance assessment.

Here's a breakdown of the information that can be extracted or inferred based on your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

MISSING: The document does not explicitly state numerical acceptance criteria (e.g., "The device must achieve >90% sensitivity"). It only generically states that performance was comparable.

Reported Device Performance (General Statements):

2. Sample Size Used for the Test Set and Data Provenance

MISSING: The document does not specify the sample size (number of urine specimens) used for the performance assessment.

Data Provenance: The study was conducted "in clinical setting by typical users." This suggests prospective data collection, likely within US-based healthcare settings given the FDA submission. The document doesn't explicitly state the country of origin, but it's implied to be within the jurisdiction of the submitting company (Bayer Corporation, Elkhart, Indiana, USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

MISSING: The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions comparison to "commonly used laboratory methods." This implies that the ground truth was established by these reference methods, likely performed by trained laboratory personnel.

4. Adjudication Method for the Test Set

MISSING: The document does not describe any adjudication method (e.g., 2+1, 3+1, none). The comparison was made against "commonly used laboratory methods."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

NO: The document does not describe a multi-reader, multi-case comparative effectiveness study with or without AI assistance. The device is a reagent strip for urinalysis, not an AI-powered diagnostic tool. The "readers" are either humans performing visual interpretation or the CLINITEK® Urine Chemistry Analyzers. The comparison is between the "NEW MULTIPLES" Reagent Strips (read visually or instrumentally) and "current MULTISTIX® 10 SG Reagent Strips and commonly used laboratory methods."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

YES (conceptually, for instrumental reading): The device can be "read instrumentally, using the CLINITEK® family of Urine Chemistry Analyzers." When read instrumentally, this represents an "algorithm only" performance (the analyzer's internal algorithms interpreting the color changes). The performance of this instrumental reading was compared to existing methods.

7. Type of Ground Truth Used

The ground truth was established by "commonly used laboratory methods." This implies various laboratory reference tests relevant to each analyte (e.g., quantitative protein assays, enzymatic creatinine assays, culture for UTI, etc.) rather than expert consensus on visual interpretation, pathology, or outcomes data directly.

8. Sample Size for the Training Set

NOT APPLICABLE / MISSING: The document does not describe a "training set" in the context of machine learning or AI. The product is a chemical reagent strip. The development process would involve extensive R&D and formulation optimization, but not typically a "training set" for an learnable algorithm.

9. How the Ground Truth for the Training Set Was Established

NOT APPLICABLE / MISSING: As there's no mention of a training set in the AI sense, this information is not provided. The development of the reagent strips involved chemical principles and optimizations rather than data-driven algorithm training.

Ask a specific question about this device

MICROALBUSTIX Reagent Strips (OTC) are intended for home use by testing persons at risk for developing kidney damage
MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria), creatinine in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips (OTC) provide semiquantitative results and are intended for home use by persons at risk of developing kidney disease.

MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips (OTC) are dipped into a urine specimen and "read" visually by comparing the color of the strip to a color chart on the label. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.

The provided text describes the MICROALBUSTIX™ Reagent Strips (OTC) and the study conducted to demonstrate their performance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table. However, the performance assessment concludes and effectively acts as the acceptance criteria that were met.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "clinical and home use settings" and that "studies demonstrated that lay users can obtain clinical test results," implying a test set, but the number of participants or urine samples is not provided.
• Data Provenance: Not explicitly stated, though it's implied the studies were conducted in the US, as it's a US FDA submission. It refers to "clinical and home use settings," but doesn't specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not explicitly stated. The study compared results obtained by lay users to "currently used laboratory tests for microalbumin and creatinine in urine" and to "results obtained by health care professionals." This implies that the ground truth was established by laboratory methods and/or healthcare professionals, but the specific number or qualifications of these professionals beyond their general role are not provided.

4. Adjudication Method for the Test Set:

• Not explicitly stated. The document indicates a comparison between lay user results and "current methods" or "health care professionals," but doesn't describe any specific adjudication process (e.g., 2+1 review, etc.).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size:

• MRMC Study: The description implies a type of comparative effectiveness study in that lay users' performance was compared to "current methods" or "health care professionals." However, it is not formally described as a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" in the context of radiology or similar fields where that term is often used. It's more of a comparison of a new device's home-user performance against established laboratory/professional methods.
• Effect Size: Not quantified. The study concludes that lay users can obtain "substantially equivalent" and "comparable" results, but no specific effect size (e.g., in terms of sensitivity, specificity, accuracy improvement, or statistical significance of performance differences) is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Yes, in a way. The device itself is a "standalone" diagnostic device (reagent strip with visual read). The "human-in-the-loop" is the lay user who reads the strip. The study explicitly tests the performance of the device as read by lay users against established laboratory methods, which is the intended standalone performance from the user's perspective. It's not an "algorithm-only" study in the modern AI sense, but rather a study of the device's performance when used as intended without professional interpretation.

7. The Type of Ground Truth Used:

• Ground Truth: The ground truth was established using "currently used laboratory tests for microalbumin and creatinine in urine." This suggests a laboratory reference method or clinical gold standard as the ground truth.

8. The Sample Size for the Training Set:

• Not mentioned. The document describes performance assessment through clinical and home-use studies, but does not provide information about a separate training set. This is typical for traditional (non-AI/machine learning) diagnostic devices, which don't have a "training set" in the same way.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as a "training set" in the context of machine learning is not described for this device. The device's performance relies on the chemical reactions of the reagent strips.

Ask a specific question about this device

The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Microalbumin is an in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine. Antibodies to albumin combine with albumin in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 340 and 700 nm, is directly proportional to the concentration of microalbumin in the sample.

Here's a breakdown of the acceptance criteria and study information for the µAlb device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The text mentions "comparative performance studies were conducted" and "precision studies were conducted using two levels of control material." It does not provide the specific number of human urine samples used for the method comparison or the number of replicates/samples for the precision studies.
• Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is an in vitro diagnostic (IVD) assay for quantitative determination of albumin, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this type of device is typically established by comparative analysis with a legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used when multiple human readers interpret results for establishing ground truth in subjective assessments. This device involves quantitative measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted device or an imaging device, thus an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The study described is a standalone performance assessment of the µAlb assay. It is an in vitro diagnostic device, and its performance is evaluated directly through chemical analysis and comparison to a predicate device, not in conjunction with human interpretation of its results on a case-by-case basis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" (or reference standard) for the comparative performance study was the K-ASSAY® Microalbumin on the Hitachi® 717 Analyzer. The study demonstrated substantial equivalence by comparing the µAlb assay's results against this predicate device, which itself is an established method for microalbumin quantitation.

8. The sample size for the training set

• Not applicable. This document describes the validation of a new in vitro diagnostic assay (based on immunoassay principles), not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device